Back to Multiple Sclerosis

NCT06351592

NCT06351592
Recruiting Phase 2 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You have muscle weakness caused by ALS, and genetic testing has shown you carry a change in the SOD1 gene that is known or likely to cause ALS
  • Your lungs are working at 50% or more of the expected level for someone your age, sex, and height (measured while sitting or standing upright)
  • Your Body Mass Index (BMI) — a measure of body weight relative to height — is 35 or below at the time of your screening appointment
  • If you are currently taking riluzole or edaravone (common ALS medicines), you have been on a stable, unchanged dose for at least 4 weeks before starting the trial and are expected to stay on that dose throughout the study
  • Your blood platelet count (cells that help blood clot) is above 50,000 per microliter of blood
  • Your blood pressure readings are within a normal range, as defined by the trial guidelines

Who may not be able to join:

  • You are currently taking part in another clinical trial that involves a treatment or intervention
  • You have previously had a tracheostomy (a surgical opening in the throat to help with breathing)
  • You have been diagnosed with dementia, as assessed by the trial doctor
  • You have had uncontrolled mental health conditions — such as psychosis, thoughts of suicide, or untreated major depression — in the past 30 days
  • You have a history of brain or spinal disease or injury that could interfere with a lumbar puncture (spinal tap) procedure or affect safety assessments (confirm with trial site)
  • You have an implanted device that drains fluid from around the brain or spinal cord, or a catheter implanted in the central nervous system
  • The trial doctor has any other concern that your participation could affect the study results or put you at additional risk
  • You were admitted to hospital for more than 24 hours for any reason other than ALS within 30 days before your screening appointment
  • You have received a treatment called tofersen within the 6 months before your screening appointment

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Regeneron Pharmaceuticals
Registry
clinicaltrials_gov
Start date
28 August 2024
Est. completion
21 March 2032

Where this trial is recruiting

🇦🇺 Australia 🇧🇪 Belgium 🇨🇦 Canada 🇯🇵 Japan 🇰🇷 South Korea 🇸🇪 Sweden 🇹🇼 Taiwan

3 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Incidence of Treatment-Emergent Adverse Event (TEAEs) in participants treated with ALN-SOD; Severity of TEAEs in participants treated with ALN-SOD

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov